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Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial.

Trials; 18(1): 601, 2017 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-29258572

BACKGROUND:

Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling.

METHODS/DESIGN:

BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months. The trial will also evaluate the improvement in the immune/inflammatory responses mediated by B and T lymphocytes. Omics field (metabolomics and proteomics) will help to understand these responses by molecular events.

DISCUSSION:

BATTLE-AMI is aimed to (1) evaluate the role of subsets of lymphocytes on microcirculation improvement and (2) show how the choice of statin/antiplatelet therapy may affect cardiac remodeling after acute myocardial infarction with ST elevation.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02428374 . Registered on 28 September 2014.

Assuntos

Anti-Inflamatórios/administração & dosagem Linfócitos B/efeitos dos fármacos Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem Mediadores da Inflamação/sangue Inibidores da Agregação de Plaquetas/administração & dosagem Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico Linfócitos T/efeitos dos fármacos Terapia Trombolítica Adenosina/administração & dosagem Adenosina/análogos & derivados Anti-Inflamatórios/efeitos adversos Linfócitos B/imunologia Linfócitos B/metabolismo Biomarcadores/sangue Brasil Protocolos Clínicos Angiografia Coronária Quimioterapia Combinada ELISPOT Ezetimiba/administração & dosagem Feminino Citometria de Fluxo Humanos Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos Imagem por Ressonância Magnética Masculino Metabolômica Inibidores da Agregação de Plaquetas/efeitos adversos Proteômica Projetos de Pesquisa Rosuvastatina Cálcica/administração & dosagem Infarto do Miocárdio com Supradesnível do Segmento ST/sangue Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem Infarto do Miocárdio com Supradesnível do Segmento ST/imunologia Sinvastatina/administração & dosagem Volume Sistólico/efeitos dos fármacos Linfócitos T/imunologia Linfócitos T/metabolismo Terapia Trombolítica/efeitos adversos Ticlopidina/administração & dosagem Ticlopidina/análogos & derivados Fatores de Tempo Resultado do Tratamento Função Ventricular Esquerda/efeitos dos fármacos Remodelação Ventricular/efeitos dos fármacos